Short answer: In the 182-day placebo-controlled AndroGel 1.62% trial, the most common reaction was increased PSA: 11.1% on AndroGel vs 0% on placebo. Emotional lability (mood swings) was 2.6%, and hypertension, raised hematocrit or hemoglobin, and contact dermatitis were each 2.1%, all vs 0% on placebo. 10.7% stopped because of side effects. A boxed warning covers testosterone passing to children through skin contact.
What AndroGel is approved for: AndroGel 1.62% is approved as testosterone replacement in adult males with low or absent natural testosterone due to primary hypogonadism (testicular failure) or hypogonadotropic hypogonadism (a pituitary or hypothalamus cause). The label says safety and efficacy have not been established in men with "age-related" (late-onset) hypogonadism or in males under 18 (section 1).
Source
ANDROGEL (testosterone gel) 1.62% for topical use, prescribing information and Medication Guide. ASCEND Therapeutics US. DailyMed, version published November 17, 2025. DailyMed setid f4e8d29b-8707-4d47-e053-2a95a90aecee
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
Children who were exposed to testosterone gel through someone else have developed male-type changes (virilization). Children should avoid contact with unwashed or unclothed skin where a man has applied the gel. The label says patients should strictly follow the instructions for use.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on AndroGel.
| Adverse Reaction | AndroGel 1.62% N=234 | Placebo N=40 |
|---|---|---|
| PSA increased* | 26 (11.1%) | 0% |
| Emotional lability** | 6 (2.6%) | 0% |
| Hypertension | 5 (2.1%) | 0% |
| Hematocrit or hemoglobin increased | 5 (2.1%) | 0% |
| Contact dermatitis*** | 5 (2.1%) | 0% |
Double-blind, placebo-controlled period of 182 days: 234 hypogonadal men on AndroGel 1.62% and 40 on placebo. Reactions listed were more frequent on AndroGel than placebo.
Table notes: * PSA increased counts values above 4.0 ng/mL or an average rise over 0.75 ng/mL on two measurements, plus reported events. ** Emotional lability includes mood swings, affective disorder, impatience, anger and aggression. *** Contact dermatitis includes 4 men with dermatitis away from the application site.
25 men on AndroGel 1.62% (10.7%) stopped treatment in the double-blind period because of side effects, 17 of them for increased PSA.
Application-site reactions were reported in 2 of 234 men (0.9%) in the double-blind period and 3 of 219 (1.4%) in the open-label period. None stopped the study because of them.
Blood pressure: in 169 men with 24-hour readings, systolic rose by an average of 1.9 mm Hg and diastolic by 1.3 mm Hg after 16 weeks. In men already on blood pressure medicine, the rise was 3.0/2.2 mm Hg.
In the TRAVERSE heart-safety study of 5198 men, major heart events were 7.0% on AndroGel 1.62% vs 7.3% on placebo. Irregular heartbeats needing treatment (5.2% vs 3.3%), atrial fibrillation (3.5% vs 2.4%), acute kidney injury (2.3% vs 1.5%) and bone fracture (3.5% vs 2.5%) were more common on AndroGel.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Testosterone passing to others. Children exposed to the gel through contact have shown enlarged penis or clitoris, pubic hair, increased erections and libido, aggressive behavior and advanced bone age. Most cases improved once exposure stopped, but a few did not fully return to normal. Women and children should avoid unwashed or uncovered application sites.
Polycythemia (high red blood cells). Hematocrit is checked before starting, again 3 to 6 months after starting, and then once a year. If it is high, treatment is stopped until it comes down.
Blood clots. Deep vein thrombosis and pulmonary embolism have been reported with testosterone products. In TRAVERSE, clots occurred in 1.7% on AndroGel 1.62% vs 1.2% on placebo. If a clot is suspected, AndroGel is stopped.
Enlarged prostate and prostate cancer. Men with an enlarged prostate (BPH) may see their symptoms worsen, and androgens may raise prostate cancer risk. The label says to check for prostate cancer before and during treatment.
Blood pressure increases. AndroGel 1.62% can raise blood pressure, which can raise heart risk over time. Blood pressure is checked periodically, and it is not recommended with uncontrolled high blood pressure.
Abuse and testosterone level checks. Testosterone has been abused at higher-than-approved doses, often with other anabolic steroids, which can cause serious heart and mental health problems. If abuse is suspected, serum testosterone is checked.
Not for use in women. AndroGel 1.62% is not indicated for women because of a lack of controlled studies and possible masculinizing effects.
Sperm production. Large doses of testosterone can suppress sperm production, which could lower sperm count.
Liver effects. Long use of high-dose oral 17-alpha-alkyl androgens has been linked to serious liver problems. The label says AndroGel 1.62% is not known to cause these effects.
Edema (fluid retention). Androgens can cause the body to hold salt and water. Swelling, with or without heart failure, can be serious in people with heart, kidney or liver disease.
Gynecomastia. Breast enlargement may develop and persist.
Sleep apnea. Testosterone may worsen sleep apnea, especially with obesity or chronic lung disease.
Lipid changes. Blood fats can change, which may require a dose change or stopping testosterone. Lipids are checked periodically, especially after starting.
High calcium. In cancer patients at risk of high calcium, AndroGel is used with caution and calcium is checked regularly.
Thyroid lab values. Androgens can lower thyroxine-binding globulin and total T4 on lab tests, but free thyroid hormone stays the same and there is no sign of thyroid disease.
Flammability. The gel contains alcohol and is flammable, so fire, flames and smoking are avoided until it has dried.
From the Medication Guide that comes with AndroGel:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.